OBJECTIVE To mine and analyze the adverse drug reaction(ADE)signal for soradenib,and to provide reference for clinical safe drug use.METHODS A total of 72 quarterly adverse reaction reports from the fourth quarter of 2005 to the third quarter of 2023 were collected from the FDA adverse events reporting system(FAERS)database.The ADE reports caused by sorafenib were mined and analyzed using the reporting odds ratio(ROR)method and proportional reporting ratio(PRR)method.RESULTS A total of 18148 ADE reports of sor-afenib were collected,and a total of 689 effective ADE signals were detected,involving 26 systematic and organ clas-sifications,mainly focusing on gastrointestinal disorders,general disorders and administration site conditions,skin and subcutaneous tissue disorders.The top 3 ADE frequency were diarrhea(n=2741),hand-foot skin reaction(n=2097)and rash(n=1587).The top 3 ADE intensity were abnormal prothrombin elevation(ROR=326.03),alpha-fetoprotein elevation(ROR=189.82)and hand-foot skin reaction(ROR=75.10).The majority of ADEs occurred within 30 days of sorafenib administration.CONCLUSION Patient medication should be evaluated when sorafenib is used.During treatment,patients'gastrointestinal and skin reactions should be closely monitored to ensure safe med-ication.
关键词
索拉非尼/不良事件/信号挖掘/报告比值比法/比例报告比值法
Key words
Sorafenib/Adverse event/Signal mining/Reporting odds ratio method/Proportional reporting ratio method
维普
万方数据